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Phase II Study of TAS-109 to Treat Advanced Colorectal Cancer

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00824161
First received: January 14, 2009
Last updated: April 20, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to evaluate progression free survival primarily. The secondary objectives are to evaluate the antitumor activity, as assessed by objective tumor response, duration of clinical benefit, overall survival, and the safety profile of TAS-109


Condition Intervention Phase
Advanced Colorectal Cancer
 Drug: TAS-109
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of TAS-109 Given by Continuous Intravenous 14-day Infusion in Patients With Chemotherapy-refractory Advanced Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taiho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Percentage of Progression Free Survival [ Time Frame: From date of randomization until date of the first documented progressive disease (PD) or death from any cause, whichever came first, assessed up to 3 months. ] [ Designated as safety issue: No ]
    The primary endpoint was percentage of progression free survival as defined by the percentage of patients without progressive disease(PD)or death, whichever came first, at 3 months of therapy.


Secondary Outcome Measures:
  • Antitumor Activity [ Time Frame: From the date of initial treatment until the date of the first objective documentation of PD or death from any cause. ] [ Designated as safety issue: No ]
    Per RECIST Criteria and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall response rate was defined as percentage of patients of CR plus PR in ITT population.

  • Overall Survival [ Time Frame: From the initial treatment until 12 months after enrollment of the last patient. ] [ Designated as safety issue: No ]
    Overall survival is defined as the period from the date of first dose of TAS-109 to death date.


Enrollment: 28
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
TAS-109
 Drug: TAS-109

14-day continuous central intravenous infusion at a dose of 2.0 mg/m2/day followed by a 7-day rest period.

Number of cycles: until unacceptable toxicity or disease progression requires discontinuation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed colorectal adenocarcinoma
  • Received prior therapy, at least two regimens, containing a fluoropyrimidine, oxaliplatin, and irinotecan
  • Have at least one measurable tumor, as defined by RECIST
  • Must be capable of maintaining a central venous line access

Exclusion Criteria:

  • Had previous anti-tumor therapy in the 3 weeks prior to study entry
  • Have not recovered from all toxicities (excluding alopecia) from prior therapy to baseline or ≤grade 1 prior to study entry
  • Have another malignancy in the past 3 years except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00824161

Locations
United States, New York
NYU Cancer Institute
East 34th Street, New York, New York, United States, NY 10016
United States, Texas
The University of Texas M.D. Anderson Cancer Center
Holcombe Boulevard, Houston, Texas, United States, TX 77030
The Center for Cancer and Blood Disorders
West Magnolia Avenue, Fort Worth, Texas, United States, TX 76104
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Henry Xiong, M.D., Ph.D. The Center for Cancer and Blood Disorders
  More Information

No publications provided

Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00824161     History of Changes
Other Study ID Numbers: TAS109-0403
Study First Received: January 14, 2009
Results First Received: June 21, 2011
Last Updated: April 20, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013